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The Smiths Medical Thera-Heat™ Heated Humidifier is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases. The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.

A Neonate Ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

A Neonate Heated Wire Ventilator Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

The Thera-Heat™ Heated Humidifier system is a respiratory gas humidificr according to a 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to warm and add humidity to the breathing gases that are administered to the patient. The Thera-Heat™ Heated Humidifier system warms and adds water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water. The humidification chamber is an auto-fill style. The water supply (liquid reservoir) is a prefilled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.

The system can be operated using a conventional breathing tube (non-heated Adult versions only) in both limbs, or a heated breathing tube in the inspiratory limb only (Adult and Neonate versions), or a heated breathing tube in both limbs (Adult and Neonate versions). The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient thereby reducing condensation and pooling of water and controlling the relative humidity. Thera-Heat™ Heated Humidifier sets and controls the heating of the humidification chamber and the breathing tube. The caregiver first sets the unit to the desired patient temperature and then sets a humidity value that is scaled by the controller based on the desired patient temperature. Thera-Heat™ Heated Humidifier will maintain the selected temperature at the patient and the humidification chamber output temperature based on the humidity value.

Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.

A Heated Wire Ventilator Breathing Circuit is a disposable device compromised of 10 mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heaterwire harness subassembly. After the gas is warmed and humidified in the water chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the Thera-Heat™ Heated Humidifier. The breathing circuits may be comprised of a dual limb (Adult and Neonate versions) or single limb circuit (Adult versions only). The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as water traps, etc. can be added in to the overall assembly creating different product variations.

The provided text describes the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits. It outlines functional performance, safety standards, and electromagnetic compliance. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance specific to a new AI/medical device's performance metrics (like sensitivity, specificity, or accuracy) and a study that proves it meets said criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the given text. The document states that the Thera-Heat™ Heated Humidifier meets safety and performance standards like UL60601-1/IEC 60601-1, CAN/CSA C22.2 No. 60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690 (USA), and ISO8185. It also mentions that the device "meets the safety requirements" and "complies with the performance and safety standards." However, it does not present specific quantitative acceptance criteria (e.g., "temperature output must be within +/- 0.5°C") and then report the device's measured performance against those criteria.

The only specific performance detail mentioned is an exception: "Clause 51.6.2 the Thera-Heat™ generates a high priority alarm in the event that the airway temperature is at or above 41℃. This event does cause the Thera-Heat™ to generate an alarm and stops the heating of the humidification chamber and the heated circuit." This describes a safety mechanism, not a general performance metric.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The document states "Non-clinical testing of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits have been conducted including mechanical, electrical, and software for functional performance, temperature accuracy under environmental conditions, and test standards for electromagnetic immunity." It does not specify the sample sizes (e.g., number of units tested, number of test runs) or the nature of the data (e.g., laboratory simulations, animal studies, human data). It also does not mention data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. This section is typically relevant for studies involving human interpretation or expert consensus for ground truth establishment (e.g., in diagnostic AI). For a hardware device like a humidifier, "ground truth" would likely refer to measurements from calibrated instruments, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. Adjudication methods are usually relevant for studies where there's subjectivity in ground truth determination, often involving multiple experts (e.g., in medical image analysis). This is not applicable to the type of non-clinical testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The Thera-Heat™ device is a humidifier, not a diagnostic AI system, so this type of study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided in the requested context. The device is a physical humidifier with software control. Its "standalone performance" is what the non-clinical testing already assesses (mechanical, electrical, software for functional performance). There isn't an "algorithm only" component separate from the device's function in the way an AI diagnostic algorithm would be.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this device, the "ground truth" for the non-clinical testing would have been established through objective measurements using calibrated instruments and reference standards. For example, temperature accuracy would be compared against a known, accurate temperature measurement device. Electromagnetic compliance would be verified against established test standards (e.g., IEC60601-1-2). Functional performance would be assessed against engineering specifications. The document doesn't explicitly state "calibrated instruments" but this is the implied method for such device testing.

8. The sample size for the training set:

This information is not provided. "Training set" is primarily relevant for machine learning algorithms. While the device has "Software... controlled using a microcontroller," there's no indication that it utilizes machine learning requiring a distinct training set. The software's performance would be validated through traditional software testing and verification methods, not typically a "training set" in the AI sense.

9. How the ground truth for the training set was established:

This information is not provided/not applicable for the same reasons as point 8.

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